Obesity
Conditions
Keywords
Adolescent
Brief summary
This study tests the feasibility and acceptability of a numberless behavioral digital scale (BDS) intervention combined with motivational interviewing (MI) to affect lifestyle changes to promote weight loss in adolescents who are obese. Half of the participants will receive this intervention, while the other half will use a digital scale along with the standard adolescent weight loss program.
Detailed description
The proposed pilot project seeks to enhance motivation for lifestyle change in adolescents who are obese. It will test a novel intervention that combines modified MI-based counseling and BDS. We will test the feasibility of the intervention over a 12-week period, with 24-week follow-up compared to use of standard digital scale. All participants will undergo the standard adolescent weight loss program, which includes monthly clinic visits with dietary and physical activity counseling. The MI intervention will include modified MI, brief weekly telephone reinforcement, and use of a BDS. The BDS with its mobile app offers daily feedback through colors, daily missions to promote healthy habits, and weekly healthy tips from nutritionists. In addition to the primary outcome of feasibility (daily weighing) investigators will also explore the intervention's effect on motivation, psychological outcomes and various aspects of feasibility and acceptability.
Interventions
BEHAVIORALNumberless BDS
Participants perform daily weighing using a numberless BDS with feedback from app (color codes, challenges), in conjunction with modified motivational interviewing (clinic visits and weekly telephone calls), and the standard adolescent weight loss program.
BEHAVIORALDigital Scale
Participants perform daily weighing using a digital scale (number readout), in conjunction with standard adolescent weight loss program
BEHAVIORALModified Motivational Interviewing
Modified motivational interviewing (clinic visits and weekly telephone calls), and the standard adolescent weight loss program.
Sponsors
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 12 and 18 years * BMI greater than or equal to 95th percentile for age and sex group or BMI greater than or equal to 35 kg/m\^2 * Participant (not parent) is able to read and understand English (app is in English) * Smartphone device with Wi-Fi and app capability * Willingness to be randomized to any condition
Exclusion criteria
Age 19 years or older * Developmental delay * Inability to provide informed consent * Any medical condition that, in the opinion of the PI, would place the participant at increased risk * Use of an investigational agent in the 30 days prior to signing informed consent * History of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would , in the opinion of the PI, make it difficult for the participant to comply with study procedures or follow instructions * Females who are pregnant or lactating, by verbal report * Pre-existing conditions (i.e paralysis, heart failure, severe autism or mental retardation, psychosis, etc.) * Prisoners * Lack of transportation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Modified MI and BDS | 24 weeks | Attendance at in-clinic visits, completion of weekly phone calls, and daily weighing based on BDS app data collected at 24 week assessment. |
| Acceptability of Modified MI and BDS | 24 weeks | Number of participants in each group who are lost to follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anthropometrics | 24 weeks | Body Mass Index (BMI) |
| Bio-impedence measures | 24 weeks | Measures body fat (%) |
| Anxiety | Change from 0 to 24 weeks | Self-reported anxiety on a scale from 0 (not at all) to 3 (severely) using the Beck Anxiety Inventory |
| Depression | Change from 0 to 24 weeks | Self-reported depression screening on a scale from 0 (not at all) to 3 (nearly every day) using the PHQ-9: Modified for Teens |
Countries
United States
Outcome results
None listed